FDA 510(k) Application Details - K230999

Device Classification Name

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510(K) Number K230999
Device Name INT Vacuum Locking Syringe
Applicant Shanghai Kindly Medical Instruments Co.,Ltd
No.925,Jinyuan yi Road
Shanghai 201803 CN
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Contact Jianhai Xu
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Regulation Number

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Classification Product Code PUR
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Date Received 04/07/2023
Decision Date 02/23/2024
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K230999


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